BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS

    MDR report key: 7552818 · Received May 30, 2018

    Report

    Report Number
    2648035-2018-00790
    Event Type
    Malfunction
    Date Received
    May 30, 2018
    Date of Event
    April 30, 2018
    Report Date
    July 28, 2018
    Manufacturer
    JOHNSON AND JOHNSON SURGICAL VISION, INC.
    Product Code
    HQL
    UDI-DI
    05050474529021
    PMA / PMN Number
    P990080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN IF THE LENS WAS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION; RETURNED TO MANUFACTURER ON: 6/15/2018. DEVICE EVALUATION: THE ZA9003 LENS WAS RETURNED IT ITS ORIGINAL PACKAGE. VISUAL INSPECTION USING MICROSCOPE MAGNIFICATION WAS PERFORMED: LOOSE FIBERS/PARTICLES WERE OBSERVED ON LENS RELATED THE HANDLING OF THE UNIT OUT OF A STERILE ENVIRONMENT. RESIDUES OF LUBRICANT MATERIAL WERE OBSERVED ON LENS SURFACE. BOTH HAPTICS WAS OBSERVED DAMAGED/DISTORTED. SAMPLE WAS SENT TO EVANS ANALYTICAL GROUP (EAG). EVALUATION OF THE EAG LAB RESULTS/SME ASSESSMENT: FOURIER TRANSFORM INFRARED (FTIR) ANALYSIS INDICATES THAT FOREIGN DEBRIS WAS CHARACTERIZED AS A MIXTURE POSSIBLY CONTAINING AN INORGANIC SPECIES SIMILAR TO CALCIUM CARBONATE, A PROTEIN SPECIES, MOISTURE, AND AN ESTER SPECIES. MIXTURE COULD BE AN ADHESIVE DUE TO ITS TACKY NATURE. INVESTIGATION REQUEST WAS EVALUATED BY SME (SUBJECT MATTER EXPERT) TO ADDRESS THE REPORTED ISSUE. ADHESIVE MATERIAL IS NOT CONSISTENT WITH COMMON MATERIALS USED PART OF MANUFACTURING PROCESS. FURTHERMORE, THE MANUFACTURING DATA CONFIRMS NO PROCESS DEVIATION THAT MAY LEAD TO DEBRIS/PARTICLE DEPOSITION ON INTRAOCULAR LENS (IOL) AS IT GOES THROUGH VARIOUS MANUFACTURING CLEANING OPERATION AND INSPECTION CONTROL. THE REPORTED COMPLAINT WAS VERIFIED. HOWEVER, IT CANNOT CONFIRMED IF FOREIGN MATERIAL IS IDENTIFIED DURING MANUFACTURING PROCESS SINCE THE DEVICE WAS OPEN. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW OF THE PRODUCTION ORDER AND RELATED DOCUMENT REVEALED THAT THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. THERE WAS NO DISCREPANCY FOUND DURING THE REVIEW. LABELING REVIEW: THE DFU WAS REVIEWED. THE DFU ADEQUATELY PROVIDES INSTRUCTIONS AND PRECAUTIONS FOR THE PROPER USE AND HANDLING OF THE PRODUCT. CONCLUSION: BASED ON THE INVESTIGATION, RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SPOT ON THE INTRAOCULAR LENS (IOL) WHEN INSERTING IT INTO THE PATIENT'S OPERATIVE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397323 TECNIS MONOFOCAL IOLS HQL JOHNSON AND JOHNSON SURGICAL VISION, INC. ZA9003 05050474529021

    Patients

    Seq Age Sex Outcome Treatment
    1